MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB 30 STAPLER

Model Number 2030

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

Report received form insorb website.Tuesday, (b)(6) 2022 12:20 pm incident detail: insorb dermal staples.I am a patient who had dermal staples placed on 8/19 after a panniculectomy.I believe with the staples being at my waist and the act of bending has caused many of the staples to erupt through the skin partially.Resulting in one hook constantly moving in and out at the surface of the skin with every movement.You can imagine the feeling of being hooked with every movement is not comfortable.Especially when some of these hooks are in the public area.Is there an easy way to remove the staple once one side has erupted? insorb 30 stapler 2030 (b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

• Brand Name: INSORB 30 STAPLER
• Type of Device: INSORB 30 STAPLER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15397607
• MDR Text Key: 299964777
• Report Number: 1216677-2022-00262
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other